Clinical trials are an important treatment option for today’s patients, and robust and diverse participation is paramount for continued progress in developing new treatments. Despite clear benefits to the field and to individual patients, clinical research is still struggling with low overall enrollment to trials and suboptimal racial, ethnic, and socioeconomic diversity among trial participants. Lower-income patients are consistently less likely to participate in clinical trials across all subgroups.
Patients cite costs as one of the top reasons for declining clinical trial participation. Patients making less than $50,000 per year are nearly 30% less likely to enroll in cancer clinical trials. Clinical trial participation also creates financial burdens for caregivers (e.g., time off work, travel, etc.). These out-of-pocket costs exist whether a patient is participating in a clinical trial or is receiving standard care outside of a trial; however, the costs of trial participation may be higher than standard care depending on the trial’s design and/or location.
Greenphire has been engaged with a multistakeholder group of colleagues in the Equitable Access to Clinical Trials (EACT) project, an initiative hosted by LUNGevity Foundation to promote sharing best practices and foster collaborative action to advance financial neutrality for patients participating in clinical trials.
Non-medical out-of-pocket costs associated with trial participation include travel expenses, meal expenses, caregiving costs for a family member, and time away from work. Many sponsors provide support to defray these costs, which frequently include reimbursement or upfront payments for travel, lodging, meals, childcare, and other items.
Together, the participating organizations from industry, academia, and patient advocacy have developed resources for trial sponsors and site personnel to advance efforts to reduce these financial burdens on trial participants. These resources can be found online at eactproject.org.
Our group has developed a Best Practice Considerations and Recommendations guide for trial sponsors, which outlines key considerations when designing financial support programs for trial participants by:
- Categorizing non-medical items most likely to have a financial impact on prospective and current study participants
- Illustrating unique considerations for patients and caregivers under various circumstances
- Highlighting pertinent regulatory guidance around coercion and undue influence of clinical trial participants
- Recommending sponsor approaches for relieving financial burden associated with non-medical, out-of-pocket costs incurred by trial participants.
Additional resources available online include tools for clinical trial site personnel to assist in guiding conversations with trial sponsors and, separately, with patients. It is important that site staff be knowledgeable about both the needs of their patients and how program offerings from sponsors can support them—and where they may fall short.
As such, we designed a “patient needs assessment” checklist to gather information from patients about their non-medical financial needs both before enrolling in a clinical trial and periodically throughout the trial, as their needs may change. A second checklist can be used when discussing new trials with sponsors, offering a convenient way to document details about financial support programs for specific clinical trials.
The EACT Initiative is also addressing policy barriers to greater provision and utilization of financial support programs for clinical trial participants. The current legislative and regulatory landscape creates tax and legal complications for sponsors and trial participants; we describe these complications in an issue brief and make policy recommendations to mitigate them.
We encourage all stakeholders to review these resources and join Greenphire in working to advance clinical trial participation by reducing financial barriers for patients.
